Brisbane ALIF Device, Gladstone ALIF Device

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove, AU 2066 NSW November 29, 2017 Re: K172019 Trade/Device Name: Brisbane ALIF Device, Gladstone ALIF Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: October 27, 2017 Received: October 30, 2017 Dear Dr. Brazil: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172019 ### Device Name Brisbane ALIF Device, Gladstone ALIF Device ### Indications for Use (Describe) The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF systems are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The Brisbane and Gladstone ALIF systems may be used as stand-alone devices or in conjunction with supplemental fixation. When used as a stand-alone device the subject devices must be used with all three screws. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 2 510(K) SUMMARY | Manufacturer: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade<br>Name: | Brisbane ALIF Device<br>Gladstone ALIF Device | | Common Name: | Lumbar Intervertebral Fusion Device | | Contact: | Dr. Declan Brazil<br>Managing Director of Signature Orthopaedics | | Prepared By: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia<br>Phone: +61 (2) 9428 5181<br>Fax: +61 (2) 8456 6065 | | Date Prepared: | June 29th, 2017 | | Classification: | Class II per 21 CFR 888.3080: Intervertebral Body Fusion Device<br>(OVD) | | Predicate<br>Devices: | Primary Predicate:<br>Spine MIDLINE II-TiTM (K141942)<br><br>Additional Predicates:<br>Benvenue Medical Inc Luna 360 Interbody System (K142023)<br>K2M Chesapeake Spinal System (K133494)<br>Spineart DYNAMIK Lumbar Interbody Device (K081888)<br><br>Reference Predicate:<br>Signature Orthopaedics NOOSA Anterior Lumbar Plate Screw<br>(K163625) | ### Device Description: The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF cages are manufactured from PEEK-OPTIMA LT1 per ASTM-F2026. The Screws for Brisbane and Gladstone ALIF cages are manufactured from Ti6A14V alloy per ISO 5832-3 and ASTM-F136. The Brisbane and Gladstone ALIF cages consist of a wedge-shaped geometry and intended for implantation by an anterior approach. The cages are hollow to allow loading of bone graft. The cages are wedge shaped to restore lordosis of the fused vertebral bodies. The superior and inferior surfaces have serrated teeth to resist expulsion. The cages have three holes each on their anterior faces to facilitate the use of titanium bone screws. The use of the bone screws make the subject cages stand-alone cages. The superior and inferior {4}------------------------------------------------ surfaces of Brisbane ALIF cage is Titanium Plasma Spray (TPS) coated per ASTM-F1580. ### Indications for Use The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF systems are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The Brisbane and Gladstone ALIF systems may be used as stand-alone devices or in conjunction with supplemental fixation. When used as a stand-alone device the subject devices must be used with all three screws. ### Performance Testing: Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Brisbane ALIF and Gladstone ALIF cages are adequate for anticipated invivo use. Non-clinical testings carried out on the worst case of the two systems as identified Finite Element Analysis (FEA) were: - Static and dynamic compression and compression shear testing per ASTM-F2077 - . Subsidence testing ASTM-F2267 - . Screw insertion testing per ASTM-F543 - Screw pull-out testing per ASTM-F543 - . Screw torque to failure testing per ASTM-F543 Also the coating on the Brisbane ALIF cage has undergone the following testings: - Powder Chemistry per ASTM-F1580 - . Coating Chemistry per ASTM-F1580 - . Coating Thickness per ASTM-F1854-09 - . Percent Porosity per ASTM-F1854-09 - . Coating Roughness per ASTM-F854-09 - Static Shear per ASTM-F1044-05 - . Static Tensile per ASTM-F1147-05 - . Shear Fatigue per ASTM-F1160-05 - Abrasion per ASTM-F1978-00 ### Substantial Equivalence: The Brisbane and Gladstone ALIF cages have the same intended use, indication for use, materials and similar design as the Centinel Spine MIDLINE II-Ti™ (K141942), K2M Chesapeake Spinal System (K133494), Spineart DYNAMIK Lumbar Interbody Device (K081888), Benvenue Medical Inc Luna 360 Interbody System (K142023) and Signature Orthopaedics NOOSA Anterior Lumbar Plate Screw (K163625). Non-clinical testing results support the substantial equivalence decision. The subject devices are expected to perform adequately during clinical use. ### Conclusion: {5}------------------------------------------------ Technical comparison of the subject and predicate devices demonstrates substantial equivalence in device design, intended use, indications for use and material. Non-clinical data support the substantial equivalence of the device.